The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.
Category Archives: Food & Drug Recalls
FDA approves first buprenorphine implant for treatment of opioid dependence
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Voluntary Recall On Certain Backroad Country Brand Sunflower Kernel Products
Millersburg, OH – Troyer Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, and WALNUT HALVES/PIECES PREPACKAGED, is recalling a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
FDA issues final food defense regulation
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.
C. J. Dannemiller Co. Annouces Recall of "Sunflower Kernels, Roasted and Salted" and "Sunflower Kernels, Roasted No Salt" Because of Possible Listeria monocytogenes
C. J. Dannemiller Co. is recalling SunOpta 50# bags and 30# cases of roasted sunflower kernels roasted and salted, and sunflower kernels roasted no salt because they have the potential to be contaminated with Listeria.
E S Foods Recalls Meal Breaks Containing Sunflower Seeds Because of Possible Health Risk
E S Foods of Woodbury, NY is recalling 3700 cases of Meal Breaks items containing individually packed Sunrich Natural Sunflower Kernels (Roasted & Salted), Net Wt 1 oz., because the sunflower seeds have the potential to be contaminated with Listeria monocytogenes.
Hickory Harvest Expands Recall of Certain Sunflower Kernel Products Because of Possible Listeria Monocytogenes
Hickory Harvest Foods, under advice from its sunflower kernel supplier, SunOpta, is expanding their recall of a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
First Source Recalls "Various Products Containing Sunflower Kernels Received From Our Supplier Sunopta" Because of Possible Health Risk
FIRST SOURCE of Tonawanda, NY, is recalling the following items because they have the potential to be contaminated with Listeria monocytogenes:
Food Gusto, Inc. Issues Allergy Alert on Undeclared Milk in Birdy 3 in 1 Coffee Mix (Robusta)
Food Gusto, Inc. of Paterson, NJ, is recalling its Birdy 3 in 1 coffee mix (Robusta) because product contains undeclared milk. People who have an allergy or serve sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Ultimate Nutrition Issues Allergy Alert on Possible Undeclared Milk Allergen in Amino Gold Products
Ultimate Nutrition Inc. of Farmington, CT, is recalling its dietary supplement, Amino Gold because they may contain undeclared milk in the form of hydrolyzed whey protein. People who have allergies to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.